Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

38276–38300 of 40449

HighFDA (Devices)·Z-1496-2013·2013-06-12
Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.
Product
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1499-2013·2013-06-12
Stryker T5 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1474-2013·2013-06-12
Hill-Rom Recalls SlingBar 360 Patient Lifting Devices Due to Impalement Risk
Hill-Rom is recalling 16 SlingBar 360 patient lifting devices because a retrospective review found a potential for impalement if a person falls onto the hooks.
Product
SlingBar 360. Designed to meet the needs for lifting humans.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1493-2013·2013-06-12
Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.
Product
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1502-2013·2013-06-12
Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Product
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1473-2013·2013-06-12
Hill-Rom Recalls SlingBar 350 Patient Lifting Devices Due to Impalement Risk
Hill-Rom is recalling 3,556 SlingBar 350 patient lifting devices because a retrospective review found four units may present a potential for impalement if a person falls onto the hooks.
Product
SlingBar 350. Designed to meet the needs for lifting humans.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2013·2013-06-12
Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects
Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.
Product
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2013·2013-06-12
Hill-Rom SlingBar Standard Recalled for Potential Impalement Hazard
Hill-Rom is recalling 726 SlingBar Standard units because a retrospective review found a potential for impalement if a person falls onto the hooks.
Product
SlingBar Standard. Designed to meet the needs for lifting humans.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1487-2013·2013-06-12
AGFA DX-D 100 X-Ray System Recalled for Unintended Movement
AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.
Product
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1492-2013·2013-06-12
Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach
Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1440-2013·2013-06-12
Zeiss OPMI Pentero C Surgical Microscope Ceiling Mount Recall
Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.
Product
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1465-2013·2013-06-12
Biomet Recalls Active Articulation E1 Hip Bearing Implants Due to Labeling Errors
Biomet is recalling 8 units of Active Articulation E1 hip bearing implants because outer and inner labels display incorrect or conflicting outer diameter sizes.
Product
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1490-2013·2013-06-12
Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1514-2013·2013-06-12
Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
Product
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1463-2013·2013-06-12
Intuitive Surgical Recalls da Vinci 5 mm Instrument Cannulae for Inspection Changes
Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.
Product
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1486-2013·2013-06-12
Coloplast Recalls Digitex Sutures Due to Incorrect Expiration Date Labeling
Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.
Product
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1484-2013·2013-06-12
Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.
Product
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1497-2013·2013-06-12
Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1446-2013·2013-06-12
Leica Microsystems Recalls LPC Fine Mesh Cassettes for Closure Failure
Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.
Product
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1512-2013·2013-06-12
Siemens ADVIA Centaur iPTH Assay Recalled for Variability
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1517-2013·2013-06-12
Invatec Diver C.E. Aspiration Catheters Recalled for Labeling Issues
Invatec Llc is recalling 177 Diver C.E. aspiration catheters because the labeled indications for use were not included in the existing regulatory clearance.
Product
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1513-2013·2013-06-12
Siemens ADVIA Centaur iPTH Assay Recalled for Variability
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1451-2013·2013-06-12
Maytex Comfort Ear-Loop Face Masks Recalled for Performance Failures
Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.
Product
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1498-2013·2013-06-12
Stryker Instruments Toga Sterile Barrier Recall
Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Product
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1464-2013·2013-06-12
Intuitive Surgical Recalls da Vinci 5 mm Flared Instrument Cannulae
Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.
Product
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
Category
Medical Device
Distribution
Distributed nationwide

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38276–38300 of 40449